U. Oz, Suna Sibel Rizvanoğlu, Emrah Şefik Abamor, Göhkan Cengi̇z, Hale Berber, Serap Derman, Müjde Eryilmaz, Asuman Bozkir
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引用次数: 0
摘要
目的:本研究的目的是开发两性霉素B负载聚合物纳米颗粒,并测定两性霉素B纳米配方样品和市售两性霉素B样品与参考两性霉素B标准的效价,根据美国药典详细的方案。材料与方法:采用单乳法制备两性霉素B纳米颗粒。采用美国药典规定的圆盘扩散法对AmB纳米制剂和市售两性霉素B与两性霉素B标准品的抑菌效力进行比较。结果与讨论:成功制备了载两性霉素B -聚乙二醇- B -聚己内酯纳米粒子,其平均水动力直径为215.14±0.72 nm, PDI值为0.18±0.02。高效液相色谱法测定两性霉素B包封率为66.4±1.42%。经计算,商用两性霉素B的效价为95.7%,而纳米两性霉素B的效价为99.1%,表明使用聚合物纳米颗粒作为递送系统是有利的。
Objective: The aim of this study is the development of Amphotericin B loaded polymeric nanoparticles and the determination of the potency of Amphotericin B nanoformulation samples and commercially supplied Amphotericin B samples in comparison with reference Amphotericin B standard, according to the protocol detailed in the United States Pharmacopoeia.
Material and Method: Amphotericin B nanoparticles were fabricated using single emulsion method. The comparison of the potencies of the AmB nanoformulation and commercial Amphotericin B with the antimicrobial potency of the reference Amphotericin B standard was performed using the disk diffusion method specified in the United States Pharmacopeia.
Result and Discussion: Amphotericin B loaded poly(ethylene glycol)-b-poly(ɛ-caprolactone) nanoparticles successfully developed having the average hydrodynamic diameter of 215.14±0.72 nm and PDI value of 0.18±0.02. The Amphotericin B encapsulation efficiency, which was determined using an HPLC method, was 66.4±1.42%. The % potency of commercial Amphotericin B was calculated as 95.7%, while the % potency of the nanoformulation of Amphotericin B was calculated as 99.1%, indicating the favor of utilizing polymeric nanoparticles as delivery systems.